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NCT04745988
An Open Label Phase 2 Study to Evaluate the Safety and Efficacy of Lenvatinib With Pembrolizumab or Lenvatinib, Pembrolizumab and FLOT in the Neoadjuvant / Adjuvant Treatment for Patients With Gastric Cancer
Conditions: Gastric Cancer
Sex: All
Ages: 20 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 43
Sponsor: National Cancer Center Hospital East
Location: National Cancer Center Hospital East Kashiwa Chiba
Summary
This study is an open label phase 2 study to evaluate the safety and efficacy of Lenvatinib with Pembrolizumab or Lenvatinib, Pembrolizumab and FLOT in the neoadjuvant / adjuvant treatment for Patients with Gastric Cancer.
Eligibility Criteria
Inclusion Criteria:
1. Have gastric and gastroesophageal junction adenocarcinoma
2. Untreated and cT2-4 and/or cN+ without evidence of metastatic disease
3. Patients at least 20 years of age on the day of providing consent.
4. Patients with a performance status of 0 or 1 on the Eastern Cooperative Oncology Group.
5. Patients with adequate organ function at the time of enrollment as defined below:
* Neutrophil count ≥1500mm3
* Platelet count ≥10 × 100,000/mm3
* Hemoglobin (Hb) ≥ 9.0 g/dL,
* Total bilirubin ≤1.5 mg/dL
* AST (GOT) and ALT (GPT) ≤ 100 IU/L
* Creatinine ≤1.5 mg/dL
* Urinary protein : It satisfies one of the following (if any of the inspection criteria are satisfied, other examination may not be carried out) (i) urinary protein (test paper method) is 2+ or less (ii) Urine Protein Creatinine (UPC) ratio \
Source: ClinicalTrials.gov (NCT04745988). StuddyBuddy aggregates publicly available trial information.